The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a sixth COVID-19 vaccine, after the product by French pharmaceutical company Valneva was found to meet the required safety, quality and effectiveness standards.
The UK’s independent medicines regulator is the first in the world to approve the Valneva vaccine which becomes the sixth COVID-19 vaccine to be granted an MHRA authorisation.
It is also the first, whole-virus inactivated COVID-19 vaccine to gain regulatory approval in the UK. With this type of vaccine, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response to the COVID-19 virus. This process is widely used already in the production of flu and polio vaccines.
Dr June Raine, MHRA Chief Executive, said: “Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”
Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines, said: “The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence are pleased to say that we have advised that the benefit risk balance is positive. The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.”
Each type of vaccine has a different pattern of antibody response over time. For the Valneva vaccine, two doses are required before a robust antibody response is raised. This means that people will need to be made aware that protection will only start after two doses.
The storage temperature for the Valneva vaccine – of 2°C to 8°C – is similar to that of a domestic fridge, making it appropriate for use in countries where storage at very low temperatures is not possible.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence.
“VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this authorization could pave the way for the availability of an alternative vaccine solution for the UK population.
“We continue to receive messages every day from people who are looking for a more traditional vaccine approach.
“We believe that this new approval could also lead to additional marketing authorizations in other regions of the world.
“I would like to personally thank all the people who have been supporting us in this endeavour and our internal teams for all their hard work.”
(Lead image: Valneva)
Wales extends COVID-19 testing throughout July
Welsh Health Minister, Eluned Morgan has confirmed that access to free LFD tests will be extended in Wales until July 31st 2022.
Tests will be available to the public that are showing symptoms of coronavirus (high temperature a new, continuous cough, a loss or change to your sense of smell or taste), alongside free access for people visiting someone eligible for new COVID-19 treatments.
The announcement comes following a rise in cases, with The Office for National Statistics recent survey reporting an increase in cases across the UK. An estimated 1 in 45 people in Wales currently have COVID-19.
The emergence of the BA.4 and BA.5 sub-variants are also contributing to this increase as they become more dominant across the UK.
The health minister has also announced the following testing will continue to be in place –
- LFD and PCR testing for those eligible for COVID-19 treatments.
- PCR testing for COVID-19 and other respiratory viruses for symptomatic care home residents and prisoners.
- PCR and LFD testing under the patient testing framework and when clinically advised including pre-operative hospital patients and care home residents returning from inpatient hospital stays
- LFD testing for symptomatic health and social care staff.
- Twice weekly LFD tests for asymptomatic testing for health and social care staff
- Those visiting people in care homes should continue to test using tests provided by the care home they are visiting.
Self-isolation payments of £500 will end on 30th June 2022, whilst the COVID-19 Statutory Sick Pay Enhancement scheme will be extended until 31st August 2022 to support social care staff to stay away from work due to testing positive.
Minister for Health and Social Services, Eluned Morgan, said: “Testing has been an effective tool in breaking the chain of transmission and with an increase in cases its vital that we keep testing in place to protect the most vulnerable in our society. As we have seen before, Covid can quickly change, I am announcing this extension in response to the changing picture and new variants of concern.
“I would also ask people to take protective measures to protect the more vulnerable in the community, wear masks in health and care settings, stay at home if you test positive, and take up the offer for the vaccine. We know that the vaccine is the best way to protect yourself, I would urge those eligible to have their spring booster if they have not already had it, the booster is available until June 30.
“Covid has not gone away, whilst we are learning to live safely with it, we will continue to monitor the situation and as we have done for the last two years, we will work together to Keep Wales Safe.”
Coronavirus regulations to end in Wales
First Minister Mark Drakeford today said Wales can look forward to a brighter future, as the last remaining coronavirus protections in law come to an end.
After more than two years of living with coronavirus regulations, these will expire on Monday May 30 when the requirement to wear a face covering in health and care settings ends.
But the Welsh Government will continue to recommend people take simple steps to protect their health – including wearing face coverings in health and care settings – as Wales moves beyond the emergency response to the pandemic.
First Minister Mark Drakeford said: “The pandemic has had a profound impact on all our lives – everyone has made sacrifices and changes over the last two years. But it is thanks to all your efforts that we can move beyond the emergency response while still living safely with this virus.
“I want to thank everyone for all you have done to protect yourselves and your loved ones. You have followed the rules and you have kept Wales safe.
“This three-week review of the coronavirus regulations is a significant milestone – we are completing our careful and gradual transition away from legal protections and away from the emergency response to the pandemic.”
The public health situation is continuing to improve in Wales – results from recent ONS Coronavirus Infection Surveys show the number of people with Covid-19 is falling.
But in the past week, the four UK chief medical officers have warned about the risk from new variants – BA.4 and BA.5.
The First Minister said Wales will remain alert to these and is ready to scale up testing and vaccination arrangements once again if the public health situation changes.
He added: “We remain alert to the threat of new and emerging variants, and we will be ready to respond if we see a rapid spread of the virus, causing widespread harm.
“Continuing to take simple steps, including staying up to date with vaccinations; self-isolating if you have Covid-19 symptoms and maintaining good hand hygiene, will be important in helping us all to enjoy a safer and brighter future together.”
From Monday 30 May, the legal requirement to wear a face covering in health and care settings will end. This follows the outcome of the three-weekly review of coronavirus regulations and completes a gradual, phased easing of legal restrictions since January.
Over the last three weeks the public health situation has continued to improve, with the latest results from the ONS Coronavirus Infection Survey showing the percentage of people testing positive for coronavirus in Wales is falling.
The number of Covid-19 related patients has also fallen to less than 700 and is at its lowest level since 28 December 2021, although the NHS remains under pressure from a combination of emergency and pandemic pressures with a significant number of staff absences.
New COVID vaccination centre opens at Aberavon Shopping Centre
A new COVID vaccination centre for Port Talbot is opening at Aberavon Shopping Centre.
Situated next door to B&M, near the river bridge entrance, Swansea Bay Health Board say it will provide vaccinations to adults and children alike.
The first clinic will be held at the Local Vaccination Centre (LVC) on Thursday, May 26th. Slots will be available by appointment only for the time being.
The health board are asking people not to telephone the shopping centre if they want to make an appointment or if they have a general query. The health board’s booking centre can be contacted on 01792 200492 or 01639 862323.
The opening comes as the health board winds down its vaccination operation at the Bay Field Hospital near Amazon, off Fabian Way, which has been open since the first Covid vaccine was rolled out to health and social care staff in December 2020.
The final Covid vaccination clinic will be held at the Bay Mass Vaccination Centre on Wednesday, June 1st.
Blood tests will continue on that site for the time being.
Covid vaccination clinics will also continue to be scheduled at Canolfan Gorseinon Centre, in the health board’s container in the car park of Morrisons supermarket on Baglan Industrial Park and on the Immbulance mobile vaccination clinic, which stops at various venues across the Swansea Bay area.
Interim Head of Transformation, James Ruggiero, said the move to the shopping centre signals a wider change in the Covid vaccination programme.
“The Bay has been absolutely brilliant for us but thankfully, we no longer need a permanent venue of that size.
“While no one can predict exactly what will happen in the future, we do know that some people, particularly those who are vulnerable, will need Covid boosters to help maintain a level of protection against the coronavirus, which is still out there.
“This new venue is perfect for that and a bonus is that being smaller and less intimidating, it can also be used to host clinics for children aged five to 11.”
Mr Ruggiero added: “Our teams have worked hard to set up this new convenient unit and to make it as comfortable and efficient as possible.
“We hope the public welcome it and enjoy popping to the other shops to pick up a bargain once they’ve come in for their vaccination.”
The Aberafan Shopping Centre LVC will be open between 9.30am and 4.30pm. Vaccinations are on an appointment-only basis for now.
The first vaccinations will be for the spring booster which, in line with JCVI guidance, is being given to those aged 75 and over, older care home residents and those aged 12 and over who are immunosuppressed.
The health board will shortly be announcing clinic dates for those aged five to 11 in June.
A Covid booster programme is due to run in the autumn, with interim JCVI advice saying that Residents in a care home for older adults and staff working in care homes for older adults; Frontline health and social care workers; All those 65 years of age and over; and adults aged 16 to 65 years in a clinical risk group should each receive one dose.
(Lead image: Swansea Bay NHS)
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